March 31, 2017

The controlled terminology in this spreadsheet supports the CDISC protocol standards, building 
on the work of related efforts focused on the Protocol Representation Model and clinical trial 
registration xml.This Protocol Entities terminology seeks to standardize commonly used concepts 
within a protocol while ensuring harmonization across existing CDISC terminology standards. 
Additional terminology will be developed on an ongoing basis to support all CDISC standards. 
Other future additions to the terminology set will be handled via the terminology change 
request and maintenance process.


Contents:

Archive                       		(directory for earlier file versions)
ReadMe.txt                    		(this file)
Protocol CDISC ReadMe.doc         	Copy of Excel ReadMe tab in Word format
Protocol Publication Date Stamp.txt	information regarding current version date of Protocol terminology
Protocol Terminology Changes.xls  	detailed description of term changes (Excel)
Protocol Terminology Changes.txt  	detailed description of term changes (text)
                                	(same as "Changes" tab in Excel file)
Protocol Terminology.OWL.zip		terms by codelist, OWL/RDF format
Protocol Terminology.html		terms by codelist, HTML format
Protocol Terminology.odm.xml		terms by codelist, ODM XML format
Protocol Terminology.pdf		terms by codelist, PDF format
Protocol Terminology.txt          	terms by codelist, text format
Protocol Terminology.xls          	terms by codelist, Excel format


Background:

SDTM is an international standard for clinical research data, and is approved
by the U.S. Food and Drug Administration as a standard electronic submission
format.  CDISC and NCI work together to develop and maintain SDTM controlled
terminology, which is also integrated and distributed as part of NCI
Thesaurus (NCIt).

Further information is available at:
     http://www.cancer.gov/cancertopics/terminologyresources/CDISC